Medical Device Manufacturer · US , Hopkonton , MA

Suturtek Incorporated - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2003

Recent clearances: SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE, SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17, SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Suturtek Incorporated General & Plastic Surgery ✕

4 devices

1-4 of 4

Cleared Oct 14, 2008

SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE

General & Plastic Surgery · 19d

Cleared Feb 07, 2007

SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17

General & Plastic Surgery · 66d

Cleared Sep 23, 2003

SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE

General & Plastic Surgery · 43d

Cleared Mar 17, 2003

SUTURTEK FASTCLOSE SUTURING DEVICE

General & Plastic Surgery · 54d